TRIUS GETS BOOST FOR ‘SUPERBUG’ ANTIBIOTIC

Faster FDA review for S.D. biotech’s experimental drug

An experimental antibiotic from San Diego-based Trius Therapeutics against the “superbug” MRSA has been approved by regulators for faster review and incentives to bring the drug to market.

The antibiotic, tedizolid phosphate, is now undergoing Phase 3 clinical trials by Trius to treat skin infections caused by the bacterium. MRSA is a strain of Staphylococcus aureus that has become resistant to methicillin and related antibiotics. Tedizolid is given orally and intravenously.

Under the decision by the U.S. Food and Drug Administration, tedizolid will get priority review taking an estimated eight months, Jeffrey Stein, president and CEO of Trius, said Tuesday. The FDA’s standard review process aims to complete 90 percent of reviews within 10 months.

If approved, tedizolid will also get an additional five years exclusivity against generic competitors.

Trius expects to file for approval in the third quarter, which means the drug should reach the market next year, Stein said.

Antibiotic-resistant infections have long plagued hospitals, where the frequent use of antibiotics encourages microbes to evolve resistance. And these infections are spreading outside of hospitals. Antibiotic-resistant bacteria have been found in livestock, which are given antibiotics to help them grow faster. Last month, a deadly strain of MRSA was identified in British milk.

However, few antibiotics have been approved in the last few decades. Health authorities have warned that unless something is done, microbes will progressively become more immune, causing antibiotics to lose effectiveness.

In response to this concern, Congress enacted new incentives to spur development of new antibiotics last year under what is called the GAIN (Generating Antibiotics Incentives Now) Act. Under the law, the FDA designated tedizolid as a Qualified Infectious Disease Product, providing the faster review and extended sales exclusivity.

Tedizolid is chemically similar to linezolid, another antibiotic used against MRSA. Sold under the brand name Zyvox, sales reached $1.2 billion in 2010. Trius says tedizolid is more potent, effective against a wider range of bacterial, and safer than Zyvox.